Apex Medical Serene User manual

Serene
User’s Manual

CONTENTS
ALTERNATING PRESSURE REDISTRIBUTION SYSTEM
IMPORTANT SAFEGUARDS 1
GROUNDING INSTRUCTIONS 2
INSTRUCTION 4
PRODUCT DESCRIPTION 6
INSTALLATION 10
OPERATION 12
CLEANING 13
STORAGE 14
MAINTENANCE 15
EXPECTED SERVICE LIFE 16
TROUBLE SHOOTING 17
TECHNICAL SPECIFICATION 18
APPEDNIX A: EMC INFORMATION 19
MODEL NO.: 9P-079040
Please read the manual before use

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IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE OPERATING THIS DEVICE.
DANGER - To reduce the risk of electrocution:
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store this product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.
WARNING - To reduce the risk of burns, electrocution, fire, or injury to persons:
1. Evaluate patients for entrapment risk according to facility protocol and monitor
patients appropriately.
2. Use this product according to the manual and medical professionals’ instructions.
3. Close supervision is necessary when this product is used on or near children.
Electrical burns or choking accident may result from a child swallowing a small part
detached from the device.
4. Use this product only for its intended use as described in this manual. Do not use
other mattress not recommended by the manufacturer.
5. Never operate this product if it has a damaged cord or plug, if it is not working
properly, if it has been dropped or damaged, or dropped into water. Return the
product to a service center for examination and repair.
6. Keep the cord away from heated surfaces.
7. Never block the air openings of this product or place it on a soft surface, such as a
bed or couch, where their openings may be blocked. Keep the air opening free of
lint, hair, and other similar particles.
8. Never drop or insert any object into any opening or hose.
9. Do not modify this equipment without authorization of the manufacturer.
10. Mattress covers have passed skin sensitization and skin irritation test. However, If
you suspect that you may have had or are having an allergic reaction, please
consult a physician immediately.
11. Do not leave long lengths of tubing around the top of your bed. It could lead to
strangulation.
12. Connect this product to a properly grounded outlet only. See Grounding
Instructions.
CAUTION –
1. If there is a possibility of electro-magnetic interference with mobile phones, please
increase the distance (3.3m) between devices or turn off the mobile phone.

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SAVE THESE INSTRUCTIONS
GROUNDING INSTRUCTIONS
DANGER - Improper use of the grounding plug can result in a risk of electric shock.
If repair or replacement of the cord or plug is necessary, do not connect the
grounding wire to either flat blade terminal. The wire with insulation having an
outer surface that is green with or without yellow stripes is the grounding wire.
NOTE - If the repair or replacement of the cord is necessary, please contact a
qualified electrician or serviceman. To reduce the risk of electric shock, do not
modify the cord or plug in any way.
Check with a qualified electrician or serviceman if the grounding instructions are
not completely understood, or if in doubt as to whether the product is properly
grounded.
NOTE, CAUTION AND WARNING STATEMENTS:
NOTE - Indicate some tips.
CAUTION - Indicate correct operating or maintenance procedures in order to
prevent damage to or destruction of the equipment or other property.
WARNING - Calls attention to a potential danger that requires correct procedures or
practices in order to prevent personal injury.

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SYMBOLS
Authorised representative in the European community
Manufacturer
Protected against solid foreign objects of 12,5 mm and greater;
Protection against vertically falling water drops
Temperature limitation/temperature range
Consult operating instructions for use.
"BF" symbol, indicate this product is according to the degree of
protecting against electric shock for type BF equipment
Grounding terminal
Attention, read the accompanying information carefully.
Do Not Bleach
Do Not Iron
Tumble Dry, Normal, Low Heat
Dry clean, Any Solvent Except Trichloroethylene
Machine wash, regular / normal, 95 degrees C (203 degrees F)
Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an applicable collection
point for the recycling of electrical and electronic equipment.
For more detailed information about the recycling of this
product, please contact your local city office, household waste
disposal service or the retail store where you purchased this
product.

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Introduction
1.
This manual should be used for initial set up of the system and for reference purposes.
1.1 General Information
EN 60601-1
EN 60601-1-2
EN 55011 Class B
IEC61000-3-2
IEC 61000-3-3
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical
devices to the EN 60601-1-2. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to other
devices in the vicinity. However, there is no guarantee that interference will not occur
in a particular installation. If this equipment does cause harmful interference to other
devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
￭ Reorient or relocate the receiving device.
￭ Increase the separation between the equipment.
￭ Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
￭ Consult the manufacturer or field service technician for help.

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1.2 Intended Use
This product is intended:
￭ to help and reduce the incidence of pressure ulcers while optimizing patient
comfort.
￭ for long term home care of patients suffering from pressure ulcers.
￭ for pain management as prescribed by a physician.
The product can only be operated by personnels who are qualified to perform
general nursing procedures and has received adequate training in knowledge of
prevention and treatment of pressure ulcer.
NOTE: Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
NOTE: L’équipement ne peut être utilisé s’il y a risque de mélange d’un
anesthésique inflammable avec l’air ou l’oxygène ou oxyde nitreux.

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Product Description
2.
2.1 Pump & Mattress System
1. Quick Connector for CPR
2. Pump Unit
3. Mattress
4. Mattress Foam Pocket
NOTE: An underlying mattress such foam must be used with Serene system.
2.2 Pump Unit
Front
1. Quick Connector
2. Front Panel
Rear
1. Power Switch
2. Power Socket
3. Fuses
4. Integrated Handle
5. Mounting Bracket
6. Pump Bumper
7. Air Filter

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2.3 Front Panel
1. Comfort Setting
The “Comfort Setting” controls the air pressure output. When the firmness is increased
( ), the output pressure will increase and vice versa ( ) for decreasing air
pressure. A hand check is needed to determine if patient is bottoming out. When a
patients condition has significantly changed reassess appropriateness of product and
comfort setting level
NOTE: Every time the mattress is initialized (inflated), it will automatically go to "Max
Firm" mode to hasten inflation. Once the system is ready to use, the system will go to
Static mode automatically.
NOTE: The Weight Guide indicated on Comfort Level is reference for pressure setting.
Always consult Professionals for the appropriate setting. Check if the pressure is
suitable for the patient by sliding one hand beneath the air cells at the level of the
patient's buttocks. Always leave at least 1” inch space between patient and the cell to
prevent bottoming out.
1
5
2
6
3
4

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2. Therapy Modes
A. Static
All of the air cells are equally inflated at lower pressures to redistribute body mass
over a greater surface area at a constant low pressure.
B. Seat Inflate
The Seat Inflation features additional supports to the patient during head raise
position to prevent bottoming out.
NOTE: When patient in head raised position, or only parts of the body are lying in
mattress, it is recommended to always use Seat Inflate mode and readjust the pressure
setting accordingly to prevent possible bottoming out.
3. On/off
Press On to turn on the unit. Press Off to turn off/standby the unit.
NOTE: The power switch on the side of pump must be turned on.
4. Panel Lock
Should the panel remain untouched for 5 minutes, the panel lock feature will lock the
panel with green LED light on to prevent accident from changing the setting during
normal operation. To unlock, simply by pressing the Panel Lock button for 3 seconds.
5. Max Firm
The system will go into Max Firm mode automatically when the power switch is turned
on. This insures the pump reaches its maximum operating pressure. Once the max
pressure level is reached, the pump will automatically switch into the previous
selected comfort level in STATIC mode, or the user can press the THERAPY button to
return to the previous mode. User can also use this function as full mattress inflation
during patient ingress/egress or normal nursing procedure for better support. There is
a 20 minutes time-out function to return to previous selected therapy setting.